Validation of ADaM includes the following:

  • Random sample of subject data inspected and compared between the SDTM domains and ADaM dataset; ADaM specifications are also inspected
  • Checks by the ADaM programmer: log review, code review, requirements/specifications review, spot check review (ad hoc programming/visual checks on ADaM data)
  • Programming of ADaM datasets by an independent programmer: Independent programmer programs the ADaM datasets per the requirements/specifications. The QC datasets are compared with the main ADaM datasets via PROC COMPARE
  • Pinnacle 21 or similar software: datasets are validated per CDISC and FDA validation rules

All findings are reviewed and resolved.